Study Status

Description Value
Participants Enrolled 48
Sites Enrolled 158
Study Status Active
Nickname Protocol Nickname
Description Value
Participants Enrolled 48
Sites Enrolled 158
Study Status Active
Protocol Row Id 1-1G9113
Protocol Number AA-AA-000-0000
Protocol Title Protocol Title
Nickname Protocol Nickname
Protocol Type Investigator Sponsored
Phase P3
Num Plan Site 190
Num Site Actl 176
Est Fpfv 2003-01-01
Act Fpfv 2003-01-01
Est Lplv 2021-06-01
Act Lplv 2021-06-01
Est Lpfv 2020-06-01
Act Lpfv 2020-06-01
Status Active
Num Plan Subj 1300
Num Enrolled Subj M 1301
Protocol Indication Protocol Indication
Product Product
Therapeutic Area Therapeutic Area
Protocol Product Number 123
X Rbm Flg Y

Study Overview

13 Red KRIs
94 Amber KRIs

Summary Charts

Group Overview
Flags Over Time

As of 2012-12-31, AA-AA-000-0000 has 48 participants enrolled across 158 sites. 93 Site-KRI combinations have been flagged across 29 sites as shown in the Study Overview Table above.
  • 29 sites have at least one red KRI
  • 132 sites have at least one red or amber KRI
  • 158 sites have neither red nor amber KRIS and are not shown

Results

Adverse Event Rate

Summary Charts

Summary
KRI Metric
KRI Score
KRI Score
KRI Metric
Numerator

Group Enrolled Numerator Denominator Metric Score Flag
0X139 (el-Khalifa) 2 67 1863 0.04 -2.96
0X186 (Gallegos-Neiberger) 2 98 2518 0.04 -2.69
0X162 (Campa) 2 186 4433 0.04 -2.54
0X113 (Wilde) 3 359 8172 0.04 -2.53
0X025 (Smith) 2 136 3210 0.04 -2.04
0X155 (al-Sani) 3 379 6887 0.06 2.37
0X119 (Cousins) 3 260 4695 0.06 2.08
0X091 (Ostrom) 2 195 4462 0.04 -1.95
0X138 (Black) 2 58 1454 0.04 -1.85
0X020 (Hamlin) 3 268 5985 0.04 -1.83
0X092 (al-Badour) 3 213 4795 0.04 -1.77
0X121 (Rodriguez-Cruz) 2 111 2569 0.04 -1.61
0X148 (Suess) 2 167 3742 0.04 -1.50
0X173 (el-Yusuf) 2 200 4436 0.05 -1.47
0X013 (el-Allam) 1 96 2215 0.04 -1.46
0X164 (Jiron) 1 96 2215 0.04 -1.46
0X143 (el-Salih) 3 216 4759 0.05 -1.42
0X046 (al-Daoud) 5 432 9283 0.05 -1.42
0X016 (el-Shaker) 3 245 5366 0.05 -1.41
0X176 (Salazar) 3 285 6191 0.05 -1.36
0X105 (Patalan) 2 170 3770 0.05 -1.36
0X134 (Keese) 2 143 3165 0.05 -1.22

Serious Adverse Event Rate

Summary Charts

Summary
KRI Metric
KRI Score
KRI Score
KRI Metric
Numerator

Group Enrolled Numerator Denominator Metric Score Flag
0X139 (el-Khalifa) 2 30 1863 0.02 -2.59
0X113 (Wilde) 3 170 8172 0.02 -2.50
0X186 (Gallegos-Neiberger) 2 45 2518 0.02 -2.40
0X162 (Campa) 2 90 4433 0.02 -2.07
0X157 (Arellano) 3 191 6519 0.03 2.48
0X003 (Drake) 1 59 1810 0.03 2.27
0X039 (Kimler) 1 59 1810 0.03 2.27
0X084 (Luong) 1 59 1810 0.03 2.27
0X137 (Wilson) 2 66 2105 0.03 2.06
0X046 (al-Daoud) 5 203 9283 0.02 -1.96
0X025 (Smith) 2 64 3210 0.02 -1.90
0X105 (Patalan) 2 77 3770 0.02 -1.86
0X007 (Harrison) 3 134 6250 0.02 -1.84
0X173 (el-Yusuf) 2 93 4436 0.02 -1.77
0X148 (Suess) 2 78 3742 0.02 -1.67
0X138 (Black) 2 27 1454 0.02 -1.64
0X143 (el-Salih) 3 103 4759 0.02 -1.51
0X061 (Harrison) 3 103 4676 0.02 -1.32
0X013 (el-Allam) 1 46 2215 0.02 -1.31
0X164 (Jiron) 1 46 2215 0.02 -1.31
0X092 (al-Badour) 3 106 4795 0.02 -1.29
0X134 (Keese) 2 68 3165 0.02 -1.29
0X116 (el-Ameen) 2 39 1880 0.02 -1.22
0X091 (Ostrom) 2 99 4462 0.02 -1.21
0X024 (Rinard) 3 150 6595 0.02 -1.16
0X141 (Esquibel) 2 153 6680 0.02 -1.08
0X050 (Tull) 4 164 7125 0.02 -1.05
0X166 (Garcia) 3 99 4387 0.02 -1.03

Non-Important Protocol Deviation Rate

Summary Charts

Summary
KRI Metric
KRI Score
KRI Score
KRI Metric
Numerator

Group Enrolled Numerator Denominator Metric Score Flag
0X144 (el-Kaber) 1 148 2174 0.07 2.40
0X152 (Batchelder) 1 148 2174 0.07 2.40
0X161 (Vangoey) 5 573 10223 0.06 2.22
0X153 (Voss) 2 34 1440 0.02 -2.19
0X100 (Browne) 4 154 4477 0.03 -2.09

Important Protocol Deviation Rate

Summary Charts

Summary
KRI Metric
KRI Score
KRI Score
KRI Metric
Numerator

Group Enrolled Numerator Denominator Metric Score Flag
0X125 (Pond) 3 133 4129 0.03 -2.30
0X086 (Gonzales) 2 256 4319 0.06 2.23
0X024 (Rinard) 3 371 6595 0.06 2.13

Grade 3+ Lab Abnormality Rate

Summary Charts

Summary
KRI Metric
KRI Score
KRI Score
KRI Metric
Numerator

Group Enrolled Numerator Denominator Metric Score Flag
0X088 (Correa) 1 4 1246 0.00 -3.23
0X093 (Depoyster) 2 14 465 0.03 2.46
0X171 (Hoffpauir) 2 22 2411 0.01 -2.27
0X010 (al-Radi) 5 60 5280 0.01 -2.12
0X155 (al-Sani) 3 64 3197 0.02 2.09
0X136 (Handley) 2 16 1809 0.01 -2.06
0X103 (al-Mona) 2 35 1606 0.02 2.02

Study Discontinuation Rate

Summary Charts

Summary
KRI Metric
KRI Score
KRI Score
KRI Metric
Numerator

Group Enrolled Numerator Denominator Metric Score Flag
0X153 (Voss) 2 0 9 0.00 -2.38
0X075 (Dabit) 2 22 23 0.96 2.35
0X115 (John) 1 13 12 1.08 2.29
0X024 (Rinard) 3 31 36 0.86 2.17
0X141 (Esquibel) 2 31 36 0.86 2.17
0X171 (Hoffpauir) 2 9 30 0.30 -2.14
0X121 (Rodriguez-Cruz) 2 3 15 0.20 -2.03

Treatment Discontinuation Rate

Summary Charts

Summary
KRI Metric
KRI Score
KRI Score
KRI Metric
Numerator

Group Enrolled Numerator Denominator Metric Score Flag
0X091 (Ostrom) 2 20 24 0.83 2.62
0X025 (Smith) 2 16 19 0.84 2.38
0X173 (el-Yusuf) 2 19 24 0.79 2.35
0X007 (Harrison) 3 24 34 0.71 2.16
0X101 (Flood) 2 1 20 0.05 -2.13

Query Rate

Summary Charts

Summary
KRI Metric
KRI Score
KRI Score
KRI Metric
Numerator

Group Enrolled Numerator Denominator Metric Score Flag
0X125 (Pond) 3 594 687 0.86 -2.53
0X141 (Esquibel) 2 1442 915 1.58 2.21

Outstanding Query Rate

Summary Charts

Summary
KRI Metric
KRI Score
KRI Score
KRI Metric
Numerator

Group Enrolled Numerator Denominator Metric Score Flag
0X173 (el-Yusuf) 2 27 948 0.03 2.40
0X025 (Smith) 2 19 615 0.03 2.37
0X162 (Campa) 2 26 941 0.03 2.20
0X007 (Harrison) 3 33 1255 0.03 2.19
0X066 (Lipps) 5 15 1472 0.01 -2.15
0X091 (Ostrom) 2 26 965 0.03 2.07
0X087 (Vigo) 1 8 926 0.01 -2.05

Outstanding Data Entry Rate

Summary Charts

Summary
KRI Metric
KRI Score
KRI Score
KRI Metric
Numerator

Group Enrolled Numerator Denominator Metric Score Flag
0X087 (Vigo) 1 46792 946810 0.05 -3.33
0X014 (Som) 2 29826 603929 0.05 -2.81
0X035 (el-Saladin) 2 29826 603929 0.05 -2.81
0X141 (Esquibel) 2 71565 1420199 0.05 2.36
0X133 (Pope) 1 23396 473405 0.05 -2.36
0X153 (Voss) 2 9564 187933 0.05 2.07
0X100 (Browne) 4 33054 666513 0.05 -2.01

Data Change Rate

Summary Charts

Summary
KRI Metric
KRI Score
KRI Score
KRI Metric
Numerator

Group Enrolled Numerator Denominator Metric Score Flag
0X179 (Terry) 2 156 480 0.32 2.81
0X083 (el-Aman) 1 81 234 0.35 2.64
0X171 (Hoffpauir) 2 167 761 0.22 -2.62
0X105 (Patalan) 2 115 533 0.22 -2.37
X044X (Anderson) 3 219 716 0.31 2.35
0X072 (Lopez) 2 139 442 0.31 2.23
0X065 (Hill) 2 110 347 0.32 2.07
0X136 (Handley) 2 117 526 0.22 -2.03

Screen Failure Rate

Summary Charts

Summary
KRI Metric
KRI Score
KRI Score
KRI Metric
Numerator

Group Enrolled Numerator Denominator Metric Score Flag
0X030 (Hutchinson) 1 3 114 0.03 3.22
0X076 (Farr) 2 15 1419 0.01 3.22
0X006 (al-Sultana) 3 7 579 0.01 2.56
0X095 (Gonzales) 1 9 867 0.01 2.44
0X149 (Lesley) 2 7 678 0.01 2.13
0X016 (el-Shaker) 3 12 1461 0.01 2.02

Metric Details

MetricID File GroupLevel Abbreviation Metric Numerator Denominator Model Score Type Threshold nMinDenominator
kri0001 kri0001.yaml Site AE Adverse Event Rate Adverse Events Days on Study Normal Approximation Adjusted Z-Score rate -2,-1,2,3 30
kri0002 kri0002.yaml Site SAE Serious Adverse Event Rate Serious Adverse Events Days on Study Normal Approximation Adjusted Z-Score rate -2,-1,2,3 30
kri0003 kri0003.yaml Site PD Non-Important Protocol Deviation Rate Non-Important Protocol Deviations Days on Study Normal Approximation Adjusted Z-Score rate -3,-2,2,3 30
kri0004 kri0004.yaml Site PD Important Protocol Deviation Rate Important Protocol Deviations Days on Study Normal Approximation Adjusted Z-Score rate -3,-2,2,3 30
kri0005 kri0005.yaml Site LB Grade 3+ Lab Abnormality Rate Grade 3+ Abnormal Labs Samples Total Lab Samples Normal Approximation Adjusted Z-Score binary -3,-2,2,3 30
kri0006 kri0006.yaml Site SDSC Study Discontinuation Rate Subjects Discontinued - Study Enrolled Subjects Normal Approximation Adjusted Z-Score binary -3,-2,2,3 3
kri0007 kri0007.yaml Site TDSC Treatment Discontinuation Rate Subjects Discontinued - Treatment Enrolled Subjects Normal Approximation Adjusted Z-Score binary -3,-2,2,3 3
kri0008 kri0008.yaml Site QRY Query Rate Queries Total Data Points Normal Approximation Adjusted Z-Score rate -3,-2,2,3 30
kri0009 kri0009.yaml Site OQRY Outstanding Query Rate Queries Open > 30 Days Total Queries Normal Approximation Adjusted Z-Score binary -3,-2,2,3 30
kri0010 kri0010.yaml Site ODAT Outstanding Data Entry Rate Data Pages Entered > 10 Days Total Data Pages Normal Approximation Adjusted Z-Score binary -3,-2,2,3 30
kri0011 kri0011.yaml Site CDAT Data Change Rate Data Points with 1+ Change Total Data Points Normal Approximation Adjusted Z-Score binary -3,-2,2,3 30
kri0012 kri0012.yaml Site SF Screen Failure Rate Screen Failures Screened Subjects Normal Approximation Adjusted Z-Score binary -3,-2,2,3 3